Trial Outcomes & Findings for Single and Multiple Ascending Dose Study of AMG 133 in Participants With Obesity (NCT NCT04478708)
NCT ID: NCT04478708
Last Updated: 2025-12-10
Results Overview
A TEAE was defined as any adverse event (AE) which started on or after the first dose of AMG 133. Clinically significant changes in laboratory safety tests, vital signs and 12-lead electrocardiograms (ECGs) were included as AEs.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
110 participants
Primary outcome timeframe
Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days
Results posted on
2025-12-10
Participant Flow
A total of 110 participants were enrolled into this trial in the United States between August 2020 and November 2022.
This trial comprised three parts: Parts A and B were randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) phases, respectively; and part C was an open-label, modified, MAD phase.
Participant milestones
| Measure |
Part A SAD Cohort 1 AMG 133
Participants received a single dose of 21 mg AMG 133 subcutaneously (SC).
|
Part A SAD Cohort 2 AMG 133
Participants received a single dose of 70 mg AMG 133 SC.
|
Part A SAD Cohort 3 AMG 133
Participants received a single dose of 140 mg AMG 133 SC.
|
Part A SAD Cohort 4 AMG 133
Participants received a single dose of 280 mg AMG 133 SC.
|
Part A SAD Cohort 5 AMG 133
Participants received a single dose of 560 mg AMG 133 SC.
|
Part A SAD Cohort 6 AMG 133
Participants received a single dose of 70 mg AMG 133 intravenously (IV).
|
Part A SAD SC Placebo (Cohorts 1-5, 11)
Participants received a single dose of placebo SC.
|
Part A SAD IV Placebo (Cohort 6)
Participants received a single dose of placebo IV.
|
Part B MAD Cohort 7 AMG 133
Participants received multiple doses of 140 mg AMG 133 SC every 4 weeks (Q4W).
|
Part B MAD Cohort 8 AMG 133
Participants received multiple doses of 280 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 9 AMG 133
Participants received multiple doses of 560 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 10 AMG 133
Participants received multiple doses of 560 mg AMG 133 SC Q4W. This cohort included the use of digital health tools.
|
Part B MAD Cohorts 7-9 Placebo
Participants received multiple doses of placebo SC Q4W.
|
Part B MAD Cohort 10 Placebo
Participants received multiple doses of placebo SC Q4W. This cohort included the use of digital health tools.
|
Part A SAD Cohort 11 AMG 133
Participants received a single dose of 840 mg AMG 133 SC.
|
Part C MAD Cohort 12
Participants received 2 doses of 70 mg AMG 133 SC once weekly (QW), then 2 doses of 420 mg AMG 133 SC Q4W.
|
Part C MAD Cohort 13
Participants received 4 doses of 70 mg AMG 133 SC QW, then 2 doses of 420 mg AMG 133 SC Q4W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
7
|
6
|
6
|
6
|
12
|
2
|
6
|
6
|
8
|
10
|
6
|
3
|
6
|
6
|
8
|
|
Overall Study
COMPLETED
|
6
|
5
|
5
|
6
|
5
|
5
|
11
|
2
|
5
|
5
|
3
|
5
|
5
|
3
|
5
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
0
|
1
|
1
|
1
|
0
|
1
|
1
|
5
|
5
|
1
|
0
|
1
|
0
|
4
|
Reasons for withdrawal
| Measure |
Part A SAD Cohort 1 AMG 133
Participants received a single dose of 21 mg AMG 133 subcutaneously (SC).
|
Part A SAD Cohort 2 AMG 133
Participants received a single dose of 70 mg AMG 133 SC.
|
Part A SAD Cohort 3 AMG 133
Participants received a single dose of 140 mg AMG 133 SC.
|
Part A SAD Cohort 4 AMG 133
Participants received a single dose of 280 mg AMG 133 SC.
|
Part A SAD Cohort 5 AMG 133
Participants received a single dose of 560 mg AMG 133 SC.
|
Part A SAD Cohort 6 AMG 133
Participants received a single dose of 70 mg AMG 133 intravenously (IV).
|
Part A SAD SC Placebo (Cohorts 1-5, 11)
Participants received a single dose of placebo SC.
|
Part A SAD IV Placebo (Cohort 6)
Participants received a single dose of placebo IV.
|
Part B MAD Cohort 7 AMG 133
Participants received multiple doses of 140 mg AMG 133 SC every 4 weeks (Q4W).
|
Part B MAD Cohort 8 AMG 133
Participants received multiple doses of 280 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 9 AMG 133
Participants received multiple doses of 560 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 10 AMG 133
Participants received multiple doses of 560 mg AMG 133 SC Q4W. This cohort included the use of digital health tools.
|
Part B MAD Cohorts 7-9 Placebo
Participants received multiple doses of placebo SC Q4W.
|
Part B MAD Cohort 10 Placebo
Participants received multiple doses of placebo SC Q4W. This cohort included the use of digital health tools.
|
Part A SAD Cohort 11 AMG 133
Participants received a single dose of 840 mg AMG 133 SC.
|
Part C MAD Cohort 12
Participants received 2 doses of 70 mg AMG 133 SC once weekly (QW), then 2 doses of 420 mg AMG 133 SC Q4W.
|
Part C MAD Cohort 13
Participants received 4 doses of 70 mg AMG 133 SC QW, then 2 doses of 420 mg AMG 133 SC Q4W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
2
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal of consent from study
|
0
|
1
|
2
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
4
|
3
|
0
|
0
|
1
|
0
|
4
|
Baseline Characteristics
Single and Multiple Ascending Dose Study of AMG 133 in Participants With Obesity
Baseline characteristics by cohort
| Measure |
Part A SAD Cohort 1 AMG 133
n=6 Participants
Participants received a single dose of 21 mg AMG 133 SC.
|
Part A SAD Cohort 2 AMG 133
n=6 Participants
Participants received a single dose of 70 mg AMG 133 SC.
|
Part A SAD Cohort 3 AMG 133
n=7 Participants
Participants received a single dose of 140 mg AMG 133 SC.
|
Part A SAD Cohort 4 AMG 133
n=6 Participants
Participants received a single dose of 280 mg AMG 133 SC.
|
Part A SAD Cohort 5 AMG 133
n=6 Participants
Participants received a single dose of 560 mg AMG 133 SC.
|
Part A SAD Cohort 6 AMG 133
n=6 Participants
Participants received a single dose of 70 mg AMG 133 IV.
|
Part A SAD SC Placebo (Cohorts 1-5, 11)
n=12 Participants
Participants received a single dose of placebo SC.
|
Part A SAD IV Placebo (Cohort 6)
n=2 Participants
Participants received a single dose of placebo IV.
|
Part B MAD Cohort 7 AMG 133
n=6 Participants
Participants received multiple doses of 140 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 8 AMG 133
n=6 Participants
Participants received multiple doses of 280 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 9 AMG 133
n=8 Participants
Participants received multiple doses of 560 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 10 AMG 133
n=10 Participants
Participants received multiple doses of 560 mg AMG 133 SC Q4W. This cohort included the use of digital health tools.
|
Part B MAD Cohorts 7-9 Placebo
n=6 Participants
Participants received multiple doses of placebo SC Q4W.
|
Part B MAD Cohort 10 Placebo
n=3 Participants
Participants received multiple doses of placebo SC Q4W. This cohort included the use of digital health tools.
|
Part A SAD Cohort 11 AMG 133
n=6 Participants
Participants received a single dose of 840 mg AMG 133 SC.
|
Part C MAD Cohort 12
n=6 Participants
Participants received 2 doses of 70 mg AMG 133 SC QW, then 2 doses of 420 mg AMG 133 SC Q4W.
|
Part C MAD Cohort 13
n=8 Participants
Participants received 4 doses of 70 mg AMG 133 SC QW, then 2 doses of 420 mg AMG 133 SC Q4W.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=352 Participants
|
0 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=9 Participants
|
6 Participants
n=32 Participants
|
7 Participants
n=18 Participants
|
6 Participants
n=78 Participants
|
6 Participants
n=16 Participants
|
6 Participants
n=82 Participants
|
12 Participants
n=13 Participants
|
2 Participants
n=335 Participants
|
6 Participants
n=451 Participants
|
6 Participants
n=163 Participants
|
8 Participants
n=71 Participants
|
10 Participants
n=400 Participants
|
6 Participants
n=22 Participants
|
3 Participants
n=22 Participants
|
6 Participants
n=22 Participants
|
6 Participants
n=23 Participants
|
8 Participants
n=352 Participants
|
109 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=352 Participants
|
1 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=9 Participants
|
1 Participants
n=32 Participants
|
3 Participants
n=18 Participants
|
2 Participants
n=78 Participants
|
1 Participants
n=16 Participants
|
2 Participants
n=82 Participants
|
4 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
1 Participants
n=451 Participants
|
2 Participants
n=163 Participants
|
7 Participants
n=71 Participants
|
5 Participants
n=400 Participants
|
4 Participants
n=22 Participants
|
1 Participants
n=22 Participants
|
1 Participants
n=22 Participants
|
5 Participants
n=23 Participants
|
3 Participants
n=352 Participants
|
47 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=9 Participants
|
5 Participants
n=32 Participants
|
4 Participants
n=18 Participants
|
4 Participants
n=78 Participants
|
5 Participants
n=16 Participants
|
4 Participants
n=82 Participants
|
8 Participants
n=13 Participants
|
2 Participants
n=335 Participants
|
5 Participants
n=451 Participants
|
4 Participants
n=163 Participants
|
1 Participants
n=71 Participants
|
5 Participants
n=400 Participants
|
2 Participants
n=22 Participants
|
2 Participants
n=22 Participants
|
5 Participants
n=22 Participants
|
1 Participants
n=23 Participants
|
5 Participants
n=352 Participants
|
63 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
2 Participants
n=32 Participants
|
1 Participants
n=18 Participants
|
1 Participants
n=78 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
5 Participants
n=13 Participants
|
2 Participants
n=335 Participants
|
2 Participants
n=451 Participants
|
4 Participants
n=163 Participants
|
4 Participants
n=71 Participants
|
10 Participants
n=400 Participants
|
2 Participants
n=22 Participants
|
3 Participants
n=22 Participants
|
5 Participants
n=22 Participants
|
1 Participants
n=23 Participants
|
2 Participants
n=352 Participants
|
45 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=9 Participants
|
4 Participants
n=32 Participants
|
6 Participants
n=18 Participants
|
5 Participants
n=78 Participants
|
6 Participants
n=16 Participants
|
6 Participants
n=82 Participants
|
7 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
4 Participants
n=451 Participants
|
2 Participants
n=163 Participants
|
4 Participants
n=71 Participants
|
0 Participants
n=400 Participants
|
4 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
1 Participants
n=22 Participants
|
5 Participants
n=23 Participants
|
6 Participants
n=352 Participants
|
65 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=352 Participants
|
0 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=78 Participants
|
1 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=352 Participants
|
1 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
1 Participants
n=451 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
1 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
2 Participants
n=352 Participants
|
4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=352 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=9 Participants
|
2 Participants
n=32 Participants
|
5 Participants
n=18 Participants
|
3 Participants
n=78 Participants
|
0 Participants
n=16 Participants
|
5 Participants
n=82 Participants
|
4 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
3 Participants
n=451 Participants
|
1 Participants
n=163 Participants
|
1 Participants
n=71 Participants
|
0 Participants
n=400 Participants
|
1 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
4 Participants
n=23 Participants
|
2 Participants
n=352 Participants
|
33 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=9 Participants
|
4 Participants
n=32 Participants
|
2 Participants
n=18 Participants
|
3 Participants
n=78 Participants
|
5 Participants
n=16 Participants
|
1 Participants
n=82 Participants
|
8 Participants
n=13 Participants
|
2 Participants
n=335 Participants
|
2 Participants
n=451 Participants
|
5 Participants
n=163 Participants
|
7 Participants
n=71 Participants
|
10 Participants
n=400 Participants
|
5 Participants
n=22 Participants
|
3 Participants
n=22 Participants
|
5 Participants
n=22 Participants
|
2 Participants
n=23 Participants
|
4 Participants
n=352 Participants
|
72 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=352 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=352 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 daysPopulation: Full analysis set: all randomized participants who received at least one dose of AMG 133 or placebo.
A TEAE was defined as any adverse event (AE) which started on or after the first dose of AMG 133. Clinically significant changes in laboratory safety tests, vital signs and 12-lead electrocardiograms (ECGs) were included as AEs.
Outcome measures
| Measure |
Part B MAD Cohort 8 AMG 133
n=6 Participants
Participants received multiple doses of 280 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 9 AMG 133
n=8 Participants
Participants received multiple doses of 560 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 10 AMG 133
n=10 Participants
Participants received multiple doses of 560 mg AMG 133 SC Q4W. This cohort included the use of digital health tools.
|
Part B MAD Cohorts 7-9 Placebo
n=6 Participants
Participants received multiple doses of placebo SC Q4W.
|
Part B MAD Cohort 10 Placebo
n=3 Participants
Participants received multiple doses of placebo SC Q4W. This cohort included the use of digital health tools.
|
Part A SAD Cohort 11 AMG 133
n=6 Participants
Participants received a single dose of 840 mg AMG 133 SC.
|
Part C MAD Cohort 12
n=6 Participants
Participants received 2 doses of 70 mg AMG 133 SC QW, then 2 doses of 420 mg AMG 133 SC Q4W.
|
Part C MAD Cohort 13
n=8 Participants
Participants received 4 doses of 70 mg AMG 133 SC QW, then 2 doses of 420 mg AMG 133 SC Q4W.
|
Part A SAD Cohort 1 AMG 133
n=6 Participants
Participants received a single dose of 21 mg AMG 133 SC.
|
Part A SAD Cohort 2 AMG 133
n=6 Participants
Participants received a single dose of 70 mg AMG 133 SC.
|
Part A SAD Cohort 3 AMG 133
n=7 Participants
Participants received a single dose of 140 mg AMG 133 SC.
|
Part A SAD Cohort 4 AMG 133
n=6 Participants
Participants received a single dose of 280 mg AMG 133 SC.
|
Part A SAD Cohort 5 AMG 133
n=6 Participants
Participants received a single dose of 560 mg AMG 133 SC.
|
Part A SAD Cohort 6 AMG 133
n=6 Participants
Participants received a single dose of 70 mg AMG 133 IV.
|
Part B MAD Cohort 7 AMG 133
n=12 Participants
Participants received multiple doses of 140 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 8 AMG 133
n=2 Participants
Participants received multiple doses of 280 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 9 AMG 133
n=6 Participants
Participants received multiple doses of 560 mg AMG 133 SC Q4W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
6 participants
|
8 participants
|
8 participants
|
3 participants
|
0 participants
|
6 participants
|
5 participants
|
6 participants
|
0 participants
|
2 participants
|
5 participants
|
6 participants
|
5 participants
|
6 participants
|
3 participants
|
1 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Cohort 1-5, 11: Day 1 predose and 1, 2, 4 and 8 hours postdose, Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 43, 57, 71, 92, 120 and 150. Cohort 6: Day 1 predose and 10 mins, 1, 2, 4 and 8 hours postdose, Day 2, 3, 4, 5, 6, 15, 22, 29, 43, 57, 71, 92, 120 and 150Population: Pharmacokinetics analysis set: all participants who received at least 1 dose of AMG 133 for whom at least 1 pharmacokinetics parameter could be adequately estimated. Participants with data available at each timepoint are presented.
The pharmacokinetic parameter estimates of intact and total AMG 133 after a single administration of AMG 133 were reported.
Outcome measures
| Measure |
Part B MAD Cohort 8 AMG 133
Participants received multiple doses of 280 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 9 AMG 133
Participants received multiple doses of 560 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 10 AMG 133
Participants received multiple doses of 560 mg AMG 133 SC Q4W. This cohort included the use of digital health tools.
|
Part B MAD Cohorts 7-9 Placebo
Participants received multiple doses of placebo SC Q4W.
|
Part B MAD Cohort 10 Placebo
Participants received multiple doses of placebo SC Q4W. This cohort included the use of digital health tools.
|
Part A SAD Cohort 11 AMG 133
Participants received a single dose of 840 mg AMG 133 SC.
|
Part C MAD Cohort 12
Participants received 2 doses of 70 mg AMG 133 SC QW, then 2 doses of 420 mg AMG 133 SC Q4W.
|
Part C MAD Cohort 13
Participants received 4 doses of 70 mg AMG 133 SC QW, then 2 doses of 420 mg AMG 133 SC Q4W.
|
Part A SAD Cohort 1 AMG 133
n=6 Participants
Participants received a single dose of 21 mg AMG 133 SC.
|
Part A SAD Cohort 2 AMG 133
n=5 Participants
Participants received a single dose of 70 mg AMG 133 SC.
|
Part A SAD Cohort 3 AMG 133
n=6 Participants
Participants received a single dose of 140 mg AMG 133 SC.
|
Part A SAD Cohort 4 AMG 133
n=6 Participants
Participants received a single dose of 280 mg AMG 133 SC.
|
Part A SAD Cohort 5 AMG 133
n=6 Participants
Participants received a single dose of 560 mg AMG 133 SC.
|
Part A SAD Cohort 6 AMG 133
n=4 Participants
Participants received a single dose of 70 mg AMG 133 IV.
|
Part B MAD Cohort 7 AMG 133
n=6 Participants
Participants received multiple doses of 140 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 8 AMG 133
Participants received multiple doses of 280 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 9 AMG 133
Participants received multiple doses of 560 mg AMG 133 SC Q4W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Maximum Observed Concentration (Cmax) of AMG 133
Total AMG 133
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.43 µg/mL
Standard Deviation 0.614
|
3.68 µg/mL
Standard Deviation 1.16
|
6.78 µg/mL
Standard Deviation 3.16
|
17.1 µg/mL
Standard Deviation 11.8
|
37.7 µg/mL
Standard Deviation 12.5
|
22.9 µg/mL
Standard Deviation 4.21
|
43.2 µg/mL
Standard Deviation 7.07
|
—
|
—
|
|
Part A: Maximum Observed Concentration (Cmax) of AMG 133
Intact AMG 133
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.31 µg/mL
Standard Deviation 0.559
|
3.42 µg/mL
Standard Deviation 1.18
|
6.09 µg/mL
Standard Deviation 2.80
|
15.7 µg/mL
Standard Deviation 11.4
|
35.8 µg/mL
Standard Deviation 10.3
|
22.7 µg/mL
Standard Deviation 4.10
|
41.5 µg/mL
Standard Deviation 7.35
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohorts 7-9: Day 1 (predose), Day 5, 7, 15, 22, 29 (predose), 36, 43, 50, 57 (predose), 61, 63, 71, 78, 85, 127, 169 and 207. Cohort 10: Day 1 (predose), Day 5, 7, 15, 22, 29 (predose), 36, 43, 50, 57 (predose), 63, 71, 78, 85, 169 and 207Population: Pharmacokinetics analysis set: all participants who received at least 1 dose of AMG 133 for whom at least 1 pharmacokinetics parameter could be adequately estimated. Participants with data available at each timepoint are presented.
The pharmacokinetic parameter estimates of intact and total AMG 133 after multiple administrations of AMG 133 were reported.
Outcome measures
| Measure |
Part B MAD Cohort 8 AMG 133
Participants received multiple doses of 280 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 9 AMG 133
Participants received multiple doses of 560 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 10 AMG 133
Participants received multiple doses of 560 mg AMG 133 SC Q4W. This cohort included the use of digital health tools.
|
Part B MAD Cohorts 7-9 Placebo
Participants received multiple doses of placebo SC Q4W.
|
Part B MAD Cohort 10 Placebo
Participants received multiple doses of placebo SC Q4W. This cohort included the use of digital health tools.
|
Part A SAD Cohort 11 AMG 133
Participants received a single dose of 840 mg AMG 133 SC.
|
Part C MAD Cohort 12
Participants received 2 doses of 70 mg AMG 133 SC QW, then 2 doses of 420 mg AMG 133 SC Q4W.
|
Part C MAD Cohort 13
Participants received 4 doses of 70 mg AMG 133 SC QW, then 2 doses of 420 mg AMG 133 SC Q4W.
|
Part A SAD Cohort 1 AMG 133
n=6 Participants
Participants received a single dose of 21 mg AMG 133 SC.
|
Part A SAD Cohort 2 AMG 133
n=6 Participants
Participants received a single dose of 70 mg AMG 133 SC.
|
Part A SAD Cohort 3 AMG 133
n=5 Participants
Participants received a single dose of 140 mg AMG 133 SC.
|
Part A SAD Cohort 4 AMG 133
n=7 Participants
Participants received a single dose of 280 mg AMG 133 SC.
|
Part A SAD Cohort 5 AMG 133
Participants received a single dose of 560 mg AMG 133 SC.
|
Part A SAD Cohort 6 AMG 133
Participants received a single dose of 70 mg AMG 133 IV.
|
Part B MAD Cohort 7 AMG 133
Participants received multiple doses of 140 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 8 AMG 133
Participants received multiple doses of 280 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 9 AMG 133
Participants received multiple doses of 560 mg AMG 133 SC Q4W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Cmax of AMG 133
Intact AMG 133 after dosing on Day 57
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
10.4 µg/mL
Standard Deviation 2.19
|
21.9 µg/mL
Standard Deviation 6.47
|
65.1 µg/mL
Standard Deviation 20.4
|
27.2 µg/mL
Standard Deviation 5.20
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Cmax of AMG 133
Total AMG 133 after dosing on Day 57
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
13.1 µg/mL
Standard Deviation 2.86
|
27.1 µg/mL
Standard Deviation 8.12
|
80.8 µg/mL
Standard Deviation 23.2
|
33.2 µg/mL
Standard Deviation 6.77
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Cmax of AMG 133
Intact AMG 133 after dosing on Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
8.30 µg/mL
Standard Deviation 2.59
|
14.5 µg/mL
Standard Deviation 5.99
|
27.4 µg/mL
Standard Deviation 12.4
|
17.8 µg/mL
Standard Deviation 5.32
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Cmax of AMG 133
Total AMG 133 after dosing on Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
8.75 µg/mL
Standard Deviation 2.56
|
16.2 µg/mL
Standard Deviation 6.52
|
30.1 µg/mL
Standard Deviation 12.3
|
18.8 µg/mL
Standard Deviation 5.15
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 1-5, 11: Day 1 predose and 1, 2, 4 and 8 hours postdose, Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 43, 57, 71, 92, 120 and 150. Cohort 6: Day 1 predose and 10 mins, 1, 2, 4 and 8 hours postdose, Day 2, 3, 4, 5, 6, 15, 22, 29, 43, 57, 71, 92, 120 and 150Population: Pharmacokinetics analysis set: all participants who received at least 1 dose of AMG 133 for whom at least 1 pharmacokinetics parameter could be adequately estimated. Participants with data available at each timepoint are presented.
The pharmacokinetic parameter estimates of intact and total AMG 133 after a single administration of AMG 133 were reported.
Outcome measures
| Measure |
Part B MAD Cohort 8 AMG 133
Participants received multiple doses of 280 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 9 AMG 133
Participants received multiple doses of 560 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 10 AMG 133
Participants received multiple doses of 560 mg AMG 133 SC Q4W. This cohort included the use of digital health tools.
|
Part B MAD Cohorts 7-9 Placebo
Participants received multiple doses of placebo SC Q4W.
|
Part B MAD Cohort 10 Placebo
Participants received multiple doses of placebo SC Q4W. This cohort included the use of digital health tools.
|
Part A SAD Cohort 11 AMG 133
Participants received a single dose of 840 mg AMG 133 SC.
|
Part C MAD Cohort 12
Participants received 2 doses of 70 mg AMG 133 SC QW, then 2 doses of 420 mg AMG 133 SC Q4W.
|
Part C MAD Cohort 13
Participants received 4 doses of 70 mg AMG 133 SC QW, then 2 doses of 420 mg AMG 133 SC Q4W.
|
Part A SAD Cohort 1 AMG 133
n=6 Participants
Participants received a single dose of 21 mg AMG 133 SC.
|
Part A SAD Cohort 2 AMG 133
n=5 Participants
Participants received a single dose of 70 mg AMG 133 SC.
|
Part A SAD Cohort 3 AMG 133
n=6 Participants
Participants received a single dose of 140 mg AMG 133 SC.
|
Part A SAD Cohort 4 AMG 133
n=6 Participants
Participants received a single dose of 280 mg AMG 133 SC.
|
Part A SAD Cohort 5 AMG 133
n=6 Participants
Participants received a single dose of 560 mg AMG 133 SC.
|
Part A SAD Cohort 6 AMG 133
n=4 Participants
Participants received a single dose of 70 mg AMG 133 IV.
|
Part B MAD Cohort 7 AMG 133
n=6 Participants
Participants received multiple doses of 140 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 8 AMG 133
Participants received multiple doses of 280 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 9 AMG 133
Participants received multiple doses of 560 mg AMG 133 SC Q4W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Time of Maximum Observed Concentration (Tmax) of AMG 133
Intact AMG 133
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
5.0 days
Interval 2.9 to 6.9
|
4.9 days
Interval 3.9 to 6.9
|
6.0 days
Interval 5.0 to 13.0
|
5.8 days
Interval 2.8 to 13.0
|
3.9 days
Interval 2.9 to 6.9
|
0.025 days
Interval 0.0049 to 0.044
|
5.4 days
Interval 1.9 to 6.0
|
—
|
—
|
|
Part A: Time of Maximum Observed Concentration (Tmax) of AMG 133
Total AMG 133
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
5.9 days
Interval 4.0 to 6.9
|
4.9 days
Interval 3.9 to 14.0
|
7.0 days
Interval 6.0 to 13.0
|
6.9 days
Interval 3.8 to 21.0
|
4.4 days
Interval 2.9 to 6.9
|
0.043 days
Interval 0.0049 to 0.044
|
5.9 days
Interval 1.9 to 6.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohorts 7-9: Day 1 (predose), Day 5, 7, 15, 22, 29 (predose), 36, 43, 50, 57 (predose), 61, 63, 71, 78, 85, 127, 169 and 207. Cohort 10: Day 1 (predose), Day 5, 7, 15, 22, 29 (predose), 36, 43, 50, 57 (predose), 63, 71, 78, 85, 169 and 207Population: Pharmacokinetics analysis set: all participants who received at least 1 dose of AMG 133 for whom at least 1 pharmacokinetics parameter could be adequately estimated. Participants with data available at each timepoint are presented.
The pharmacokinetic parameter estimates of intact and total AMG 133 after multiple administrations of AMG 133 were reported.
Outcome measures
| Measure |
Part B MAD Cohort 8 AMG 133
Participants received multiple doses of 280 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 9 AMG 133
Participants received multiple doses of 560 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 10 AMG 133
Participants received multiple doses of 560 mg AMG 133 SC Q4W. This cohort included the use of digital health tools.
|
Part B MAD Cohorts 7-9 Placebo
Participants received multiple doses of placebo SC Q4W.
|
Part B MAD Cohort 10 Placebo
Participants received multiple doses of placebo SC Q4W. This cohort included the use of digital health tools.
|
Part A SAD Cohort 11 AMG 133
Participants received a single dose of 840 mg AMG 133 SC.
|
Part C MAD Cohort 12
Participants received 2 doses of 70 mg AMG 133 SC QW, then 2 doses of 420 mg AMG 133 SC Q4W.
|
Part C MAD Cohort 13
Participants received 4 doses of 70 mg AMG 133 SC QW, then 2 doses of 420 mg AMG 133 SC Q4W.
|
Part A SAD Cohort 1 AMG 133
n=6 Participants
Participants received a single dose of 21 mg AMG 133 SC.
|
Part A SAD Cohort 2 AMG 133
n=6 Participants
Participants received a single dose of 70 mg AMG 133 SC.
|
Part A SAD Cohort 3 AMG 133
n=5 Participants
Participants received a single dose of 140 mg AMG 133 SC.
|
Part A SAD Cohort 4 AMG 133
n=7 Participants
Participants received a single dose of 280 mg AMG 133 SC.
|
Part A SAD Cohort 5 AMG 133
Participants received a single dose of 560 mg AMG 133 SC.
|
Part A SAD Cohort 6 AMG 133
Participants received a single dose of 70 mg AMG 133 IV.
|
Part B MAD Cohort 7 AMG 133
Participants received multiple doses of 140 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 8 AMG 133
Participants received multiple doses of 280 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 9 AMG 133
Participants received multiple doses of 560 mg AMG 133 SC Q4W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Tmax of AMG 133
Intact AMG 133 after dosing on Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
5.9 days
Interval 3.8 to 6.2
|
6.0 days
Interval 4.1 to 14.0
|
5.9 days
Interval 3.9 to 15.0
|
4.0 days
Interval 3.8 to 7.0
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Tmax of AMG 133
Total AMG 133 after dosing on Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6.0 days
Interval 3.8 to 6.2
|
6.0 days
Interval 4.1 to 14.0
|
5.9 days
Interval 3.9 to 15.0
|
4.0 days
Interval 3.8 to 14.0
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Tmax of AMG 133
Intact AMG 133 after dosing on Day 57
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4.7 days
Interval 4.1 to 15.0
|
4.3 days
Interval 3.7 to 6.0
|
4.1 days
Interval 4.0 to 5.1
|
6.0 days
Interval 6.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Tmax of AMG 133
Total AMG 133 after dosing on Day 57
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
5.6 days
Interval 4.1 to 7.2
|
6.2 days
Interval 3.7 to 14.0
|
4.1 days
Interval 4.0 to 5.1
|
6.0 days
Interval 6.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 1-5, 11: Day 1 predose and 1, 2, 4 and 8 hours postdose, Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 43, 57, 71, 92, 120 and 150. Cohort 6: Day 1 predose and 10 mins, 1, 2, 4 and 8 hours postdose, Day 2, 3, 4, 5, 6, 15, 22, 29, 43, 57, 71, 92, 120 and 150Population: Pharmacokinetics analysis set: all participants who received at least 1 dose of AMG 133 for whom at least 1 pharmacokinetics parameter could be adequately estimated. Participants with data available at each timepoint are presented.
The pharmacokinetic parameter estimates of intact and total AMG 133 after a single administration of AMG 133 were reported.
Outcome measures
| Measure |
Part B MAD Cohort 8 AMG 133
Participants received multiple doses of 280 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 9 AMG 133
Participants received multiple doses of 560 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 10 AMG 133
Participants received multiple doses of 560 mg AMG 133 SC Q4W. This cohort included the use of digital health tools.
|
Part B MAD Cohorts 7-9 Placebo
Participants received multiple doses of placebo SC Q4W.
|
Part B MAD Cohort 10 Placebo
Participants received multiple doses of placebo SC Q4W. This cohort included the use of digital health tools.
|
Part A SAD Cohort 11 AMG 133
Participants received a single dose of 840 mg AMG 133 SC.
|
Part C MAD Cohort 12
Participants received 2 doses of 70 mg AMG 133 SC QW, then 2 doses of 420 mg AMG 133 SC Q4W.
|
Part C MAD Cohort 13
Participants received 4 doses of 70 mg AMG 133 SC QW, then 2 doses of 420 mg AMG 133 SC Q4W.
|
Part A SAD Cohort 1 AMG 133
n=6 Participants
Participants received a single dose of 21 mg AMG 133 SC.
|
Part A SAD Cohort 2 AMG 133
n=5 Participants
Participants received a single dose of 70 mg AMG 133 SC.
|
Part A SAD Cohort 3 AMG 133
n=5 Participants
Participants received a single dose of 140 mg AMG 133 SC.
|
Part A SAD Cohort 4 AMG 133
n=6 Participants
Participants received a single dose of 280 mg AMG 133 SC.
|
Part A SAD Cohort 5 AMG 133
n=5 Participants
Participants received a single dose of 560 mg AMG 133 SC.
|
Part A SAD Cohort 6 AMG 133
n=4 Participants
Participants received a single dose of 70 mg AMG 133 IV.
|
Part B MAD Cohort 7 AMG 133
n=5 Participants
Participants received multiple doses of 140 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 8 AMG 133
Participants received multiple doses of 280 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 9 AMG 133
Participants received multiple doses of 560 mg AMG 133 SC Q4W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) of AMG 133
Intact AMG 133
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
39.0 mcg*day/mL
Standard Deviation 13.6
|
108 mcg*day/mL
Standard Deviation 35.2
|
230 mcg*day/mL
Standard Deviation 56.2
|
442 mcg*day/mL
Standard Deviation 263
|
762 mcg*day/mL
Standard Deviation 196
|
205 mcg*day/mL
Standard Deviation 67.9
|
1150 mcg*day/mL
Standard Deviation 280
|
—
|
—
|
|
Part A: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) of AMG 133
Total AMG 133
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
56.4 mcg*day/mL
Standard Deviation 20.3
|
151 mcg*day/mL
Standard Deviation 51.2
|
300 mcg*day/mL
Standard Deviation 104
|
629 mcg*day/mL
Standard Deviation 375
|
1100 mcg*day/mL
Standard Deviation 321
|
264 mcg*day/mL
Standard Deviation 112
|
1720 mcg*day/mL
Standard Deviation 468
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohorts 7-9: Day 1 (predose), Day 5, 7, 15, 22, 29 (predose), 57 (predose), 61, 63, 71, 78 and 85. Cohort 10: Day 1 (predose), Day 5, 7, 15, 22, 29 (predose), 57 (predose), 63, 71, 78 and 85Population: Pharmacokinetics analysis set: all participants who received at least 1 dose of AMG 133 for whom at least 1 pharmacokinetics parameter could be adequately estimated. Participants with data available at each timepoint are presented.
The pharmacokinetic parameter estimates of intact and total AMG 133 after multiple administrations of AMG 133 were reported. This parameter shows the AUC over the 28-day dosing interval, both from Day 1 to Day 29 (predose) and from Day 57 to Day 85.
Outcome measures
| Measure |
Part B MAD Cohort 8 AMG 133
Participants received multiple doses of 280 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 9 AMG 133
Participants received multiple doses of 560 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 10 AMG 133
Participants received multiple doses of 560 mg AMG 133 SC Q4W. This cohort included the use of digital health tools.
|
Part B MAD Cohorts 7-9 Placebo
Participants received multiple doses of placebo SC Q4W.
|
Part B MAD Cohort 10 Placebo
Participants received multiple doses of placebo SC Q4W. This cohort included the use of digital health tools.
|
Part A SAD Cohort 11 AMG 133
Participants received a single dose of 840 mg AMG 133 SC.
|
Part C MAD Cohort 12
Participants received 2 doses of 70 mg AMG 133 SC QW, then 2 doses of 420 mg AMG 133 SC Q4W.
|
Part C MAD Cohort 13
Participants received 4 doses of 70 mg AMG 133 SC QW, then 2 doses of 420 mg AMG 133 SC Q4W.
|
Part A SAD Cohort 1 AMG 133
n=6 Participants
Participants received a single dose of 21 mg AMG 133 SC.
|
Part A SAD Cohort 2 AMG 133
n=5 Participants
Participants received a single dose of 70 mg AMG 133 SC.
|
Part A SAD Cohort 3 AMG 133
n=4 Participants
Participants received a single dose of 140 mg AMG 133 SC.
|
Part A SAD Cohort 4 AMG 133
n=5 Participants
Participants received a single dose of 280 mg AMG 133 SC.
|
Part A SAD Cohort 5 AMG 133
Participants received a single dose of 560 mg AMG 133 SC.
|
Part A SAD Cohort 6 AMG 133
Participants received a single dose of 70 mg AMG 133 IV.
|
Part B MAD Cohort 7 AMG 133
Participants received multiple doses of 140 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 8 AMG 133
Participants received multiple doses of 280 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 9 AMG 133
Participants received multiple doses of 560 mg AMG 133 SC Q4W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: AUC From Day 0 to 28 (AUC0-28) of AMG 133
Total AMG 133 after dosing on Day 1 up to Day 29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
181 mcg*day/mL
Standard Deviation 26.0
|
300 mcg*day/mL
Standard Deviation 122
|
697 mcg*day/mL
Standard Deviation 244
|
419 mcg*day/mL
Standard Deviation 43.7
|
—
|
—
|
—
|
—
|
—
|
|
Part B: AUC From Day 0 to 28 (AUC0-28) of AMG 133
Intact AMG 133 after dosing on Day 57 up to Day 85
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
214 mcg*day/mL
Standard Deviation 18.7
|
443 mcg*day/mL
Standard Deviation 136
|
1220 mcg*day/mL
Standard Deviation 432
|
512 mcg*day/mL
Standard Deviation 79.7
|
—
|
—
|
—
|
—
|
—
|
|
Part B: AUC From Day 0 to 28 (AUC0-28) of AMG 133
Total AMG 133 after dosing on Day 57 up to Day 85
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
297 mcg*day/mL
Standard Deviation 27.7
|
599 mcg*day/mL
Standard Deviation 224
|
1610 mcg*day/mL
Standard Deviation 624
|
691 mcg*day/mL
Standard Deviation 114
|
—
|
—
|
—
|
—
|
—
|
|
Part B: AUC From Day 0 to 28 (AUC0-28) of AMG 133
Intact AMG 133 after dosing on Day 1 up to Day 29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
149 mcg*day/mL
Standard Deviation 23.5
|
246 mcg*day/mL
Standard Deviation 95.5
|
594 mcg*day/mL
Standard Deviation 201
|
347 mcg*day/mL
Standard Deviation 28.7
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A Cohort 1-6 and 11: Up to Day 150. Part B Cohort 7-10 and Part C Cohort 13: Up to Day 207. Part C Cohort 12: Up to Day 193Population: Full analysis set: all randomized participants who received at least one dose of AMG 133 or placebo.
The percentage of participants who developed anti-AMG 133 antibodies (binding and if positive, neutralizing to native GLP-1, when available) at any time was presented.
Outcome measures
| Measure |
Part B MAD Cohort 8 AMG 133
n=10 Participants
Participants received multiple doses of 280 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 9 AMG 133
n=6 Participants
Participants received multiple doses of 560 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 10 AMG 133
n=6 Participants
Participants received multiple doses of 560 mg AMG 133 SC Q4W. This cohort included the use of digital health tools.
|
Part B MAD Cohorts 7-9 Placebo
n=8 Participants
Participants received multiple doses of placebo SC Q4W.
|
Part B MAD Cohort 10 Placebo
Participants received multiple doses of placebo SC Q4W. This cohort included the use of digital health tools.
|
Part A SAD Cohort 11 AMG 133
Participants received a single dose of 840 mg AMG 133 SC.
|
Part C MAD Cohort 12
Participants received 2 doses of 70 mg AMG 133 SC QW, then 2 doses of 420 mg AMG 133 SC Q4W.
|
Part C MAD Cohort 13
Participants received 4 doses of 70 mg AMG 133 SC QW, then 2 doses of 420 mg AMG 133 SC Q4W.
|
Part A SAD Cohort 1 AMG 133
n=6 Participants
Participants received a single dose of 21 mg AMG 133 SC.
|
Part A SAD Cohort 2 AMG 133
n=6 Participants
Participants received a single dose of 70 mg AMG 133 SC.
|
Part A SAD Cohort 3 AMG 133
n=7 Participants
Participants received a single dose of 140 mg AMG 133 SC.
|
Part A SAD Cohort 4 AMG 133
n=6 Participants
Participants received a single dose of 280 mg AMG 133 SC.
|
Part A SAD Cohort 5 AMG 133
n=6 Participants
Participants received a single dose of 560 mg AMG 133 SC.
|
Part A SAD Cohort 6 AMG 133
n=6 Participants
Participants received a single dose of 70 mg AMG 133 IV.
|
Part B MAD Cohort 7 AMG 133
n=6 Participants
Participants received multiple doses of 140 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 8 AMG 133
n=6 Participants
Participants received multiple doses of 280 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 9 AMG 133
n=8 Participants
Participants received multiple doses of 560 mg AMG 133 SC Q4W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Anti-AMG 133 Antibody Formation
Binding antibody positive
|
30.0 percentage of participants
|
33.3 percentage of participants
|
16.7 percentage of participants
|
12.5 percentage of participants
|
—
|
—
|
—
|
—
|
16.7 percentage of participants
|
50.0 percentage of participants
|
28.6 percentage of participants
|
33.3 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
0.0 percentage of participants
|
33.3 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants With Anti-AMG 133 Antibody Formation
Neutralizing antibody positive
|
0.0 percentage of participants
|
16.7 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
—
|
—
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
16.7 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
Adverse Events
Part A SAD Cohort 1 AMG 133
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A SAD Cohort 2 AMG 133
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A SAD Cohort 3 AMG 133
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part A SAD Cohort 4 AMG 133
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part A SAD Cohort 5 AMG 133
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part A SAD Cohort 6 AMG 133
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part A SAD SC Placebo (Cohorts 1-5, 11)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A SAD IV Placebo (Cohort 6)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B MAD Cohort 7 AMG 133
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part B MAD Cohort 8 AMG 133
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part B MAD Cohort 9 AMG 133
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part B MAD Cohort 10 AMG 133
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part B MAD Cohorts 7-9 Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part B MAD Cohort 10 Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A SAD Cohort 11 AMG 133
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part C MAD Cohort 12
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part C MAD Cohort 13
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A SAD Cohort 1 AMG 133
n=6 participants at risk
Participants received a single dose of 21 mg AMG 133 SC.
|
Part A SAD Cohort 2 AMG 133
n=6 participants at risk
Participants received a single dose of 70 mg AMG 133 SC.
|
Part A SAD Cohort 3 AMG 133
n=7 participants at risk
Participants received a single dose of 140 mg AMG 133 SC.
|
Part A SAD Cohort 4 AMG 133
n=6 participants at risk
Participants received a single dose of 280 mg AMG 133 SC.
|
Part A SAD Cohort 5 AMG 133
n=6 participants at risk
Participants received a single dose of 560 mg AMG 133 SC.
|
Part A SAD Cohort 6 AMG 133
n=6 participants at risk
Participants received a single dose of 70 mg AMG 133 IV.
|
Part A SAD SC Placebo (Cohorts 1-5, 11)
n=12 participants at risk
Participants received a single dose of placebo SC.
|
Part A SAD IV Placebo (Cohort 6)
n=2 participants at risk
Participants received a single dose of placebo IV.
|
Part B MAD Cohort 7 AMG 133
n=6 participants at risk
Participants received multiple doses of 140 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 8 AMG 133
n=6 participants at risk
Participants received multiple doses of 280 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 9 AMG 133
n=8 participants at risk
Participants received multiple doses of 560 mg AMG 133 SC Q4W.
|
Part B MAD Cohort 10 AMG 133
n=10 participants at risk
Participants received multiple doses of 560 mg AMG 133 SC Q4W. This cohort included the use of digital health tools.
|
Part B MAD Cohorts 7-9 Placebo
n=6 participants at risk
Participants received multiple doses of placebo SC Q4W.
|
Part B MAD Cohort 10 Placebo
n=3 participants at risk
Participants received multiple doses of placebo SC Q4W. This cohort included the use of digital health tools.
|
Part A SAD Cohort 11 AMG 133
n=6 participants at risk
Participants received a single dose of 840 mg AMG 133 SC.
|
Part C MAD Cohort 12
n=6 participants at risk
Participants received 2 doses of 70 mg AMG 133 SC QW, then 2 doses of 420 mg AMG 133 SC Q4W.
|
Part C MAD Cohort 13
n=8 participants at risk
Participants received 4 doses of 70 mg AMG 133 SC QW, then 2 doses of 420 mg AMG 133 SC Q4W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
28.6%
2/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
50.0%
3/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
8.3%
1/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
50.0%
3/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
83.3%
5/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
50.0%
4/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
2/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
25.0%
2/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
20.0%
2/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
50.0%
3/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
57.1%
4/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
50.0%
3/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
8.3%
1/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
25.0%
2/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
57.1%
4/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
66.7%
4/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
83.3%
5/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
100.0%
6/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
25.0%
3/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
83.3%
5/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
66.7%
4/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
100.0%
8/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
30.0%
3/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
83.3%
5/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
66.7%
4/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
75.0%
6/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
8.3%
1/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
57.1%
4/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
83.3%
5/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
83.3%
5/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
66.7%
4/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
83.3%
5/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
75.0%
6/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
70.0%
7/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
66.7%
4/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
25.0%
2/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
General disorders
Chills
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
50.0%
4/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
General disorders
Early satiety
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
25.0%
2/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
General disorders
Injection site pain
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
General disorders
Injection site pruritus
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
General disorders
Injection site reaction
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
8.3%
1/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
Investigations
Amylase increased
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
Investigations
Breath sounds absent
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
Investigations
Lipase increased
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
25.0%
2/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
42.9%
3/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
8.3%
1/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
50.0%
1/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
30.0%
3/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
50.0%
3/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
37.5%
3/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
8.3%
1/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hot flush
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/12 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause mortality and serious adverse events, from enrollment to end of study; median duration (min, max) in months: 4.93 (0.13, 7.03). TEAEs from first dose of study drug until end of study; duration with median (min, max) in months: 4.93 (0.13, 7.03). TEAE time frame for Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days.
Serious adverse events and other adverse events were reported for all participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER